Who: Param Singh, vice president of clinical trial management solutions, BioPharm Systems

Adrian Hampshire, managing director, EMEA, BioPharm Systems

Paul Dobrowolskyj, senior consultant, Oracle Health Sciences

What: Webinar: "Business and Operational Risks in Clinical and Safety: Applying Appropriate Technology and Approaches to Mitigate Risk"

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company's business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

When: Thursday, November 17, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

Webinar Information: To register for this complimentary webinar, go to: https://cc.readytalk.com/r/bf2hph6dutcu

Bryant & Stratton College Online announced today that it is hosting a free webinar for network security professionals on June 29th. The webinar, Defense Against the Cyber Dark Arts, Network Security and You, will discuss trends in security procedures and the latest security technology. The online clinic is for information technology and network security professionals, Bryant & Stratton College students and graduates and prospective students considering a career in IT, such as network and security technology. The webinar begins at noon EDT and will last for about an hour. Registrations are being accepted at http://online.bryantstratton.edu/webinar/.

The topics that will be examined during the webinar include:

• The Threats
• Social Engineering
• Advanced Persistent Threats (APT)
• Uneducated Employees and Password Enforcement
• Firewalls
• Server and Desktop Hardening
• Proactive Measures
• Acceptable Use Policies
• Auditing & Monitoring
• User Education
• Learning the Tools of the Enemy

With a shift to cloud computing and VDI environments, small and midsize businesses are now the main target of cybercriminals. VDIs are becoming more common place as they offer enterprises costs savings however, they also pose new security risks. VDIs may make their users more vulnerable than ever to screen scrapers, key loggers, DNS redirection and malware. Overall making your environment less secure and expose you to critical data theft. Remote endpoints (managed or unmanaged) restrict the level of protection you can guarantee.

As businesses strive to reduce costs associated with application and data access, many organizations are finding the solution resides in leveraging existing resources to centralize applications and services. But what happens when data is accessed on your VDI from a local machine that is possibly infected with malware? That data is now susceptible to malware and theft.

Advanced malware is bypassing the best anti-malware solutions for the endpoint and conducting mass-market crime. Consumers, Commercial Bank access, and Enterprise Networks are all at risk, despite all the effort and dollars being spent

Let us teach you how to protect your VDI environment. View our Free Live Webinar about VDI Security and learn how to ensure the connection is secure and the endpoint data is protected!

With a shift to cloud computing and VDI environments, small and midsize businesses are now the main target of cyber criminals. VDIs can make your environment less secure and expose you to critical data theft. Register now for our Free Live Webinar about VDI Security!

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

Description
The field of GCP has rapidly evolved over the last 5 years and the requirements are getting tougher. Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance. This will result in trials running smoothly, data being valid and giving your drug the best chance of success in the clinic leading to approval.

Areas Covered in the seminar:

What the major systems that must be in place - the requirements.
Ways to determine how well your systems are designed.
Ways to determine how well your systems are operating.
Major pitfalls that companies run into.
If I use a CRO, how much oversight is enough.
How do I manage sites, do I have to audit them all?
How do I manage an ex USA site.
How can I get processes that everybody will follow.
Who will benefit:

This webinar will provide valuable assistance to all companies that conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. The employees who will benefit include:
QA GCP staff
Regulatory Affairs
Clinical Operations
Clinical Development
Project Managers
Drug Safety staff
Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, Pharma and venture capital industry. It provides consulting services in supply chain development and management, quality systems development and implementation, clinical development and monitoring, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

Description
Why Should You Attend:
This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control. It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA.

Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you.

Duration:

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (times Eastern)

10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)
1:00-2:00 Lunch hour
2:00-3:30 Module 3: Logical and Rational Water and Steam System Validation (1:30)
3:30-3:45 Afternoon break
3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
5:15-5:30 Q&A
Syllabus:

1. Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)

Interactive discussion that presents the basics of biofilm development and the mechanisms behind its detrimental effects on water systems and why it is so hard to control

Common biofilm examples
Biofilm basics and how it develops
Biofilm organism types in high purity water
Biofilm impact on “active” surfaces
Environmental resistances of biofilm
Biofilm impact on purification unit operations
Debunk a few water system myths
2. Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)

Interactive discussion that presents the reasons why sanitizations sometimes fail, the properties of commonly used sanitants, their relative efficacy, and how to use them.

Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don’t work)
When to sanitize
Troubleshooting sanitization problems
3. Logical and Rational Water and Steam System Validation (1:30)

Interactive discussion of the fundamentals of water system validation with emphasis on what must be done in advance before validation commences as well as the typical content of each stage in the process, how lab water system validation can (and usually should be) different from manufacturing water systems, and whether using packaged waters is a reasonable alternative to a water system for a small volume user. This module also presents the basics of Pure Steam systems validation and what attributes are appropriate to validate

Why validate a water system?
What you should know and do before you validate
Figuring out what you should validate
Validation elements and phases
Minimum validation expectations
What happens after the honeymoon is over
Is validation ever really over?
Special considerations for lab water systems
Packaged water options
Pure Steam specification & validation considerations
Pure Steam testing & troubleshooting considerations
4. Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)

Interactive discussion of how the use of more thorough sampling directions, appropriately set microbial control levels and specifications, and appropriate test controls and environmental monitoring during testing and sampling will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended roles of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best practices
Who Will Benefit:

Engineers responsible for water system design and fabrication
Maintenance personnel responsible for water system maintenance and sanitization
Microbiological personnel involved in collecting and testing water system samples
Validation personnel involved in writing and executing water system validation protocols
Quality Assurance professionals involved in deviation investigations and oversight/approval of all other water system activities as well as those involved in defending water system issues to regulatory investigators who may or may not be water experts themselves
Regulatory Affairs professionals involved in describing water and water systems in regulatory filings and also those involved with regulatory inspections
Managers and supervisors of all these disciplines who need to understand what makes water systems unique design, control, monitoring, validation, and investigative challenges.
Instructor Profile:
T.C. Soli, Ph.D. is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.

Description
Why Should You Attend:

The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience.

This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality principles that have been shown to be effective. While the "new quality" is gaining, the virtues of compliance are declining.

Attend this 4-hour webinar and learn how you can successfully implement the Quality Systems Approach in your operations. Understand how you can be an active and positive force in driving this paradigm change at your organization.

Areas Covered in the Seminar:

The current quality and regulatory paradigm.
The FD&C Act established the requirements for safety and effectiveness.
Current regulations have failed to ensure safety and effectiveness objectives.
Definition for commonly used terms.
Understanding the battle between compliance and quality.
Cross-functional relationships and their role in achieving quality effectiveness.
The Quality Constitution paves the way to cooperation and teamwork.
Transforming Juran’s Quality Loop/Spiral to the Regulatory Loop.
The Pharmaceutical Lifecycle.
The What, Where, Why, When, and How of FDA Enforcement Status.
Dissecting and Analyzing the FDA’s Quality Systems Approach (FQSA) and ICH-Q10.
Background.
Comparison of Scope.
Comparison of Purpose and Objectives.
Comparison of Contents.
Overview of Similarities between FQSA and ICH-Q10.
Overview of Differences between FQSA and ICH-Q10.
Comparisons to FDA, ISO, ICH, GHTF, and other regional regulations.
Summary Overview of Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulation and ICH Q10-Pharmaceutical Quality System.
Understanding and Applying the Common Quality System Concepts Embodied in These Standards.
People, Leadership, and Management Responsibility.
The Importance of Resource Management.
Building and Organizing the Quality System.
Achieving a State of Control.
Knowledge Management.
Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System.
Documenting Policies, Procedures, and the Quality Manual.
Achieving Product Realisation (Realization).
Lifecycles Defined.
Importance of Design To Establish the Master Records.
Risk starts with Design.
Technology Transfer.
Facilities and Equipment.
Material Controls.
Control of Outsourcing.
Process Control’s Dependency on Change Control.
Evaluation & Monitoring Activities.
Maintaining the Quality System Through Management Review and Internal Auditing.
Corrective and Preventative Action.
Technology Transfer.
Continual Improvement.
Six System Inspection Model.
Question & Answer, & Discussion.
Learning Objectives:

Discuss the current quality vs. compliance paradigm.
Explain & discuss the background , purpose and ,objectives for the Food & Drug Administration' s issuance of “The Quality Systems Approach To Pharmaceutical Good Manufacturing Practices” guidance and the ICH's issuance of ICH-Q10, Pharmaceutical Quality Systems.
Translate the terminology used in these guidances into practical and well understood, quality practices and concepts . Such terms as Quality by Design (QbD), Product Realization, Risk Management, Continual Improvement, Management Review, CAPA, will be studied and discussed.
Discuss the organization and content between the documents so that similarities and differences may be studied in order to implement these concepts effectively, efficiently, and without duplication.
Provide established tools that may be used to implement these quality practices discussed in these guidances.
Explain quality and regulatory phases as they relate to the pharmaceutical lifecycle.
The Enforcement What, How, When, and Where of these guidances.
Who Will Benefit:

Because these guidance documents focus on management's responsibility to organize for quality and manage resources, all functions are impacted directly or indirectly. Therefore , all departments would benefit from the seminar. Below is a list of functions that would benefit from attending:

Quality Organization-all levels
All functions of Senior Management
Research and Development
Production (Improve operations by applying these concepts)
Regulatory Affairs
Senior & Junior Management
Purchasing & Finance
Engineering and Maintenance
Instructor Profile:

Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight.

He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.

Description
Why Should You Attend:

The Current Good Manufacturing Practice for Finished Pharmaceuticals regulations of the US Food and Drug Administration require investigations to be conducted per 21 CFR Part §211.192 regulations.

Although this regulation has been in effect since 1978, organizations continue to struggle with the effective conduct and documentation of investigations to meet the expectations of regulatory authorities. An FDA guidance document regarding “Out-of-Specification Investigations” was finalized in 2006, but primarily covers the investigation of “chemistry-based laboratory testing of drugs regulated by the Center for Drug Evaluation and Research (CDER)”.

Establishing an effective system of conducting investigations, to ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is an essential requirement for the manufacture and commercialization of all FDA regulated products.

This webinar will discuss five key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance.
Areas Covered in the Seminar:

Attendees will learn

How to incorporate key attributes of effective investigations into the Quality System.
The role of management in planning and documenting effective investigations and assuring cGMP compliance.
How to strategically employ quality control tools in effective investigations.
Ensuring adequate Corrective Action and Preventive Action Effectiveness checks and follow-up.
Key cGMP Issues from Regulatory Authority Inspections programs.
Who Will Benefit:

This webinar will provide information to regulated industry including pharmaceutical, biotechnology, responsible for the manufacture of cGMP products. Those functional roles that would derive the most benefit from this webinar include:

VPs of Quality, Operations or Manufacturing
QA Managers/Directors
QC Managers/Directors
Quality Systems Personnel
Operations or Manufacturing Managers/Directors
Instructor Profile:

Felicia Ford-Rice, is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International, specializing in Strategic Compliance. Felicia has over twenty years experience working in Research and Development, Regulatory Affairs and Quality Assurance roles for Academia, the US Government, Vaccine and Pharmaceutical manufacturers. In previous roles she has led the creation of the following quality system elements: deviation/CAPA, investigation, effectiveness checks, management review processes, product disposition/ release, aseptic processing support, change control, product complaints, product recalls, quality agreements, EM trending, APRs, controlled documentation management, internal/external audits, supplier qualification, MRB, CRO/CMO oversight, regulatory authority inspection readiness, anti-counterfeiting communications. Felicia has also trained and directed the GMP, GLP, GCP and regulatory inspection readiness training of multidisciplinary staff, taught graduate courses on Regulatory Affairs and Quality Assurance topics for Northeastern University. She has authored technical reports, co-authored or contributed to abstracts and scientific papers published in peer review journals and presented at scientific symposia. Felicia has also served on the SCDM Editorial Board, and the PDA Annual Meeting Program Planning Committee and currently supports the HBA Membership and Marketing Committees. She is a member of PDA, RAPS, DIA, and HBA and holds a RAC Certification.

In this Food safety training learn about Food preservation, traditional heat treatment, emerging food processing technologies, sterilization, shelf stable products, low acid foods, US FDA and USDA regulations, Health Canada, new regulatory terms and definitions, novel foods, high hydrostatic pressure, microwave heating, irradiation.

Description
Why Should You Attend:
Sterilisation unit operation is directed towards achieving shelf stability or commercial sterility through microorganisms removal or inactivation including spores. Traditionally, the food industry used heat to sterilize foods. In current times, where the role of the consumer has become leading and necessary, food production systems are no longer supply-driven but become more demand-driven. As a result of consumer demands for foods that are fresher, more natural, or minimally processed and additive-free, new physical methods of treatment are emerging for shelf-life extension and are under broad development.

Essential terms and definitions of sterilization process in the production of low acid foods (LAF) will be presented. In addition, general approaches for the establishment of sterilization process using traditional thermal and emerging techniques will be discussed.

Buy : Alternative Food Preservation: Pasteurization

Learning Objectives:

Learn about new technologies that can be used for sterilisation and requirements for process design.
Assist to make the right choices to satisfy modern society requirements for safe and healthy products.
Understand the new regulatory terms and definitions.
Understand the specific emerging technologies that are the best fit for different categories of foods.
Areas Covered in the Seminar:

Food preservation technologies.
Food safety.
Low acid foods.
Traditional thermal technologies .
Advanced thermal technologies.
Regulatory terms and definitions.
Sterilization definition and techniques.
Emerging food processing technologies.
High pressure.
Microwave heating.
Packaging.
Process required microbial log reduction.
Food Safety Objective.
Safe process design.
Who Will Benefit:

Quality Assurance Managers
Production Managers
Laboratory Managers
Food Safety Personnel
HACCP Coordinators
Government Food Inspectors
Sanitation Managers
Corporate and Plant Microbiologists
Processing Engineers
Operations Supervisors and Managers
Food Technologists
Instructor Profile:
Dr. Tatiana Koutchma, is a Research Scientist in Food Processing in Agriculture and Agri-Food Canada (AAFC), Guelph Food Research Center where she leads research in food safety engineering. Before she joined the AAFC, she was an Associate Professor at the National Centre for Food Safety and Technology (NCFST) at the Illinois Institute of Technology in Chicago where she had taught courses in food processing and engineering. She received her doctoral degree in Food Process Engineering at Moscow State University of Food Production. Since 1990, she has worked in academia and government research programs, collaborating with leading food companies. Her main research focus is application of emerging processing technologies like UV light, microwave heating and high hydrostatic pressure for improved food safety, security, shelf life and product acceptability. She also initiated a research program on UV pasteurization of fresh juices and other liquid ingredients.

Dr. Koutchma is a member of the Editorial Board of the Journal of Food Processing, Food, and Bioprocess Technology; a member of the Innovative Technologies Board of PepsiCo; is an invited speaker at international symposiums and congresses; and, chairs conferences and society sections. Since 1998, she has published over 50 manuscripts and book chapters on a wide range of food processing related topics. In 2009 she completed a book on the application of UV technology for foods called “Ultraviolet Light in Food Technology: Principles and Applications”.

This webinar addresses new test methods for quantifying migration of Printing inks on food packaging materials into the packaged food and how they affect food safety law compliance.

Description
Why Should You Attend:

Packaged food worth millions of Euros has been recalled in Europe over the past four years as a result of the transfer of printing ink chemicals from the printed layer of packaging material into the packaged product. EU authorities have responded with new regulations and procedures intended to prevent such contamination. The US is likely to follow.

In the US, users and producers of food packaging are responsible for insuring that no chemicals from printing inks migrate into the packaged product. With basic testing protocols for demonstrating that chemicals from these inks do not migrate into packaged food now established through this European initiative, food packages must deal with a new scientific standard for meeting their no-migrate standard.

This webinar will present the methods and guidelines for surrogate food simulants in force now in Europe, with an eye towards their use in compliance with US food safety law.

Areas Covered in the Seminar:

Food processing facility inspections.
Indirect food additives.
Migration into food.
Migration testing and modeling.
Food simulants for migration experiments.
Packaging material traceability.
Product recall response.
Good manufacturing practices.
Surface-print ink offset mechanisms.
Who Will Benefit:

Personnel responsible for HACCP, food safety procedures, FDA compliance, product traceability and safety audits at food processing facilities
Members of the Institute of Food Technologists and American Society for Quality involved in food safety and quality assurance
Packaging engineers at companies using or supplying food packaging material
Instructor Profile:

Tom Dunn, has over thirty years experience in designing food packaging materials and operating food packaging facilities in compliance with local, state, Federal, and International safety regulations. He is past Chairman of the Flexible Packaging Association Technical Committee and the Flexible Packaging Groups of the Society of Plastics Engineers and the Technical Association of the Pulp and Paper industry.

He was an active member of the UV/EB curing industry’s committee that submitted its Food Contact Notification Application to the US FDA.

His undergraduate and Master’s degrees are from Yale University.